Deep Brain Stimulation (DBS) for the Suppression of Tremor

Inclusion criteria

• Patient or authorized representative has signed an informed consent.
• Patient is over 18 years of age.
• Patient is diagnosed with essential tremor for at least 3 years.
• Patient has a disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant).
• Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor.
• Patient will maintain a constant dose of anti-tremor medication indicated as best medical management for one (1) month prior to enrollment in study.
• Patient is available for appropriate follow-up times for the length of the study.

Exclusion criteria

• Patient is not surgical candidate;
• Patient has other clinically or medically significant disease;
• Patient has any neurological injury or disease other than essential tremor;
• Patient has any condition requiring repeated MRI scans;
• Patient has any condition requiring diathermy;
• Patients on anticoagulant medications;
• Patient has untreated clinically significant depression;
• Patient has had an electrical or electromagnetic implant (cochlear prosthesis, pacemaker etc);
• Patient has had a prior thalamotomy or surgical ablation procedure in either side of the brain;
• Patient has dementia interfering with their ability to co-operate or comply with study requirements or comprehend the informed consent (mini-mental exam score <24);
• Patient abuses drugs or alcohol;
• Patient has had botulinum toxin injections in the six (6) months prior to enrollment;
• Patient has a history of cranial surgery;
• Patient has a history of seizures;
• Patient has any metallic implants that may interfere with the functioning of the device (e.g. aneurysm clips);
• Patient has a history of stimulation intolerance in any area of the body;
• Patient is a female of child bearing potential with a positive urine pregnancy test or not using adequate contraception.